Senior Manager/Associate Director, Quality Assurance

This rapidly growing biotech, recognized for advancing novel RNA-targeted therapies, is actively seeking a Senior Manager/Associate Director of QA Vendor Management to support its expanding global pipeline. With multiple marketed products and a strong development portfolio in high-need therapeutic areas, the company is strengthening its quality organization to ensure continued excellence and compliance across programs.

This role will report to the Director of Quality and will play a key role in shaping vendor oversight, leading internal audits, and ensuring compliance with global regulations.

Qualifications:

• Bachelor’s or Master’s degree in Chemistry, Chemical Engineering, Life Sciences, or related field (advanced degree preferred).
• 8+ years of pharmaceutical/biotech industry experience, with 5+ years in GMP vendor management.
• Strong knowledge of global GMP regulations and experience conducting vendor or internal audits.
• Hands-on experience with computer system validation (CSV) and data integrity audits preferred.
• Proven ability to collaborate cross-functionally, influence stakeholders, and manage multiple priorities in a fast-paced environment.
• Experience with biologics, small molecules, medical devices, or combination products a plus.

Responsibilities:

• Lead and execute the internal audit program to ensure compliance and inspection readiness.
• Independently manage vendor audits (onsite, remote, and questionnaire-based) aligned with international regulatory standards.
• Oversee quality agreements with GMP vendors, including initiation, negotiation, and maintenance.
• Manage vendor changes, deviations, and CAPAs, ensuring timely resolution and compliance.
• Drive continuous quality improvements and monitor key performance metrics across vendor programs.

This is an excellent opportunity to join a science-driven biotech at a pivotal time of growth, where your expertise will directly impact the quality and success of its clinical and commercial programs. While the role can be fully remote, preference may be given to candidates open to a hybrid arrangement.